]>
IRCT20200404046936N3 IRCT 2020-05-18 Shahid Beheshti University of Medical Sciences "Mesh fixation with glue in hernia repair" Therapeutic outcomes of mesh fixation with suture versus glue in inguinal hernia repair with Lichtenstein method 2020-05-04 anticipated 40 Complete https://irct.ir/trial/46927 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done using a random number table. A mixture of numbers from 1 to 40 is made, and patients entering the study get the next code from the table in order. If the number is below 20 the patient will be assigned to the intervention group, and If it is above 20, he or she will be assigned to the control group. Patients in the control group will be operated with suture and the intervention group with glue, Blinding description: The patient is unaware that he or she is in the glue or suture group. N/A Comparing mesh fixation with suture versus glue in Lichtenstein inguinal hernia repair. Intervention 1: Intervention group: patients with indirect inguinal hernia candidate for Lichtenstein hernioplasty with mesh fixation with cyanoacrylate glue. Intervention 2: Control group: patients with indirect inguinal hernia candidate for Lichtenstein hernioplasty with mesh fixation with suture. Yes - There is a plan to make this available What will be shared: All the data of the patients participating in the study will be shared after the study after concealment of the identities. When: Data sharing will be possible 6 month after publishing the results. To whom: Researchers working in academic and scientific institutions. Conditions: In order to continue the study and increase the number of samples and develop the study. Where to obtain: Arash Mohammadi Tofigh via email address arash_mtofigh@yahoo.com How to obtain: Immediately after receiving the request, the applicant's person or institution will be examined and the requested file will be sent within a week Comments:
public milad karimian ghadim
no. 3, motahari alley,bahonar ave.,niavaran
Tehran Iran (Islamic Republic of) 1979836713 +98 21 2685 4694 dr.miladkarimian@yahoo.com Shahid Beheshti University of Medical Sciences scientific Arash Mohammadi Tofigh
Shahid Madani st, Imam Hossein Medical Center
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7758 5851 arash_mtofigh@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with indirect inguinal hernia no limit no limit Both Impossible to follow Recurrent hernia Long time use of anti-inflammatory drugs ASA physical status classification 3 and higher Addiction to alcohol,drugs,opium Treatment - Surgery Treatment - Surgery Intervention group: patients with indirect inguinal hernia candidate for Lichtenstein hernioplasty with mesh fixation with cyanoacrylate glue Control group: patients with indirect inguinal hernia candidate for Lichtenstein hernioplasty with mesh fixation with suture Pain. Timepoint: 1st, 8th, 24th hour post op then 1 week and 1,3,6,12 months after. Method of measurement: numeric rating scale(NRS) to assess pain.the patients rate their pain on a defined faces pain rating scale.for example, 0-10 where 0 is no pain and 10 is the worst pain imaginable. Recurrence. Timepoint: 1week-1,3,6,12 months after surgery. Method of measurement: Physical examination. Infection. Timepoint: 1 day-1 week-1 month after surgery. Method of measurement: Observation and physical exam. Duration of surgery. Timepoint: Start to the end of anesthesia in the operating room. Method of measurement: Anesthesia sheet time table. Duration of hospitalization. Timepoint: Days in hospital from the end of surgery. Method of measurement: The patients file. Hematoma. Timepoint: 8 hours-1 day-1 week after the surgery. Method of measurement: Physical examination. Seroma formation. Timepoint: 8 hours-1 day-1 week after the surgery. Method of measurement: Physical examination. Shahid Beheshti University of Medical Sciences Approved 2018-05-15 Ethics committee of Shahid Beheshti University of Medical Sciences Evin, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)